⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final...

16
October 2008/1 BTS 370 Test Uric Acid Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator # Rep Calibrator and Blank 2 Number of Calibrators # Calibrator 1 * Decimals 2 Reading Bichromatic Primary Wavelength 505 nm Reference Wavelength 670 nm Volume of Sample 8 μL Volume of Reagent 1 400 μL Volume of Reagent 2 0 μL Incubation time 1 600 s Incubation Time 2 0 Stabilisation Time 15 s OPTIONS Linearity Limit 20 mg/dL Blank Absorbance Limit 0 A Kinetic Blank Limit 2 A/min High Factor Limit # Low Factor Limit # Upper Reference Range 8.20 Lower Reference Range 2,30 Number of Controls # Control Types # Control Replicates # Washing Volume 400 μL Temperature 37 ºC # User defined parameters URIC ACID FS TBHBA Order information Cat. No. 1 3021 .. .. Notes 1. Please refer to the package insert for Uric Acid FS for detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature 2. The stability of the reagent on board the analyser is at least one month provided that contamination and evaporation are avoided. 3. Manufactured by DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany **This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Transcript of ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final...

Page 1: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test Uric Acid

Units mg/dL

Analysis Mode Final Point

Associated constituents #

Reaction Type Increase

Sample replicates 1

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Bichromatic

Primary Wavelength 505 nm

Reference Wavelength 670 nm

Volume of Sample 8 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 0 µL

Incubation time 1 600 s

Incubation Time 2 0

Stabilisation Time 15 s

OPTIONS

Linearity Limit 20 mg/dL

Blank Absorbance Limit 0 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 8.20

Lower Reference Range 2,30

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

URIC ACID FS TBHBA Order information

Cat. No. 1 3021 .. .. …

Notes

1. Please refer to the package insert for Uric Acid FS for

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 2: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test Albumin

Units g/dL

Analysis Mode Final point

Associated constituents #

Reaction Type Increase

Sample replicates 1

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Monochromatic

Primary Wavelength 670 nm

Reference Wavelength -

Volume of Sample 5 µL

Volume of Reagent 1 500 µL

Volume of Reagent 2 0 µL

Incubation time 1 300 s

Incubation Time 2 0

Stabilisation Time 5 s

OPTIONS

Linearity Limit 6 g/dL

Blank Absorbance Limit 0 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 5.2

Lower Reference Range 3.5

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

ALBUMIN FS Order information

Cat. No. 1 0220 .. .. …

Notes

1. Please refer to the package insert for Albumin FS for

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 3: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test Amylase

Units U/L

Analysis Mode Kinetic

Associated constituents #

Reaction Type Increase

Sample replicates 1

Value of the factor 4554

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Monochromatic

Primary Wavelength 405 nm

Reference Wavelength -

Volume of Sample 8 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 0 µL

Incubation time 1 50 s

Incubation Time 2 60 s

Stabilisation Time 30 s

OPTIONS

Linearity Limit 2000 U/L

Blank Absorbance Limit 1 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 100 U/L

Lower Reference Range #

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

-AMYLASE CC FS Order information

Cat. No. 1 0501 .. .. …

Notes

1. Please refer to the package insert for -Amylase CC FS for

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 4: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test TDil

Units mg/dL

Analysis Mode Differential

Associated constituents #

Reaction Type Increase

Sample replicates 1

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Monochromatic

Primary Wavelength 546 nm

Reference Wavelength -

Volume of Sample 40 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 100 µL

Incubation time 1 180 s

Incubation Time 2 300 s

Stabilisation Time 10 s

OPTIONS

Linearity Limit 10 mg/dL

Blank Absorbance Limit 1 A

Kinetic Blank Limit .2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 0.2 mg/dL

Lower Reference Range #

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

BILIRUBIN AUTO DIRECT FS Order information

Cat. No. 1 0821 .. .. …

Notes

1. Please refer to the package insert for Bilirubin Auto Direct FS

for detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 5: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test TBil

Units mg/dL

Analysis Mode Differential

Associated constituents #

Reaction Type Increase

Sample replicates 1

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Monochromatic

Primary Wavelength 546 nm

Reference Wavelength -

Volume of Sample 10 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 100 µL

Incubation time 1 300 s

Incubation Time 2 300 s

Stabilisation Time 10 s

OPTIONS

Linearity Limit 30 mg/dL

Blank Absorbance Limit 1 A

Kinetic Blank Limit .2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 1.2 mg/dL

Lower Reference Range #

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

BILIRUBIN AUTO TOTAL FS Order information

Cat. No. 1 0811 .. .. …

Notes

1. Please refer to the package insert for Bilirubin Auto Total FS

for detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 6: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test Calcium

Units mg/dL

Analysis Mode Final Point

Associated constituents #

Reaction Type Increase

Sample replicates 1

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Monochromatic

Primary Wavelength 670 nm

Reference Wavelength nm

Volume of Sample 4 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 0 µL

Incubation time 1 300 s

Incubation Time 2 0

Stabilisation Time 5 s

OPTIONS

Linearity Limit 25 mg/dL

Blank Absorbance Limit 0 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 10.3 mg/dL

Lower Reference Range 8,6 mg/dL

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

CALCIUM AS FS Order information

Cat. No. 1 1130 .. .. …

Notes

1. Please refer to the package insert for Calcium AS FS for

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 7: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test CK MB

Units U/L

Analysis Mode Kinetic

Associated constituents #

Reaction Type Increase

Sample replicates 1

Value of the factor 8254

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 0

Reading Monochromatic

Primary Wavelength 340 nm

Reference Wavelength -

Volume of Sample 16 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 0 µL

Incubation time 1 300 s

Incubation Time 2 120 s

Stabilisation Time 30 s

OPTIONS

Linearity Limit 2000 U/L

Blank Absorbance Limit 0.5 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 25 U/L

Lower Reference Range #

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

CK-MB FS Order information

Cat. No. 1 1651 .. .. …

Notes

1. Please refer to the package insert for CK-MB FS for detailed

information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 8: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test CK NAC

Units U/L

Analysis Mode Kinetic

Associated constituents #

Reaction Type Increase

Sample replicates 1

Value of the factor 4127

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 0

Reading Monochromatic

Primary Wavelength 340 nm

Reference Wavelength -

Volume of Sample 16 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 0 µL

Incubation time 1 120 s

Incubation Time 2 60 s

Stabilisation Time 10 s

OPTIONS

Linearity Limit 2000 U/L

Blank Absorbance Limit 0.5 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 171 U/L

Lower Reference Range #

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

CK-NAC FS Order information

Cat. No. 1 1601 .. .. …

Notes

1. Please refer to the package insert for CK-NAC FS for

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 9: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test Cholesterol

Units mg/dL

Analysis Mode Final Point

Associated constituents #

Reaction Type Increase

Sample replicates 1

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Bichromatic

Primary Wavelength 505 nm

Reference Wavelength 700 nm

Volume of Sample 4 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 0 µL

Incubation time 1 600 s

Incubation Time 2 0

Stabilisation Time 10 s

OPTIONS

Linearity Limit 750 mg/dL

Blank Absorbance Limit 0 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 200 mg/dL

Lower Reference Range # mg/dL

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

CHOLESTEROL FS Order information

Cat. No. 1 1300 .. .. …

Notes

1. Please refer to the package insert for Cholesterol FS for

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 10: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test Iron

Units µg/dL

Analysis Mode Dif

Associated constituents #

Reaction Type Increase

Sample replicates 1

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Monochromatic

Primary Wavelength 578 nm

Reference Wavelength -

Volume of Sample 50 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 100 µL

Incubation time 1 300 s

Incubation Time 2 300s

Stabilisation Time 5 s

OPTIONS

Linearity Limit 1000 µg/dL

Blank Absorbance Limit 0 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 5.2

Lower Reference Range 3.5

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

IRON FS Ferene Order information

Cat. No. 1 1911 .. .. …

Notes

1. Please refer to the package insert for Iron FS Ferene for

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 11: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test Glucose

Units mg/dL

Analysis Mode Final Point

Associated constituents #

Reaction Type Increase

Sample replicates 1

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Bichromatic

Primary Wavelength 505 nm

Reference Wavelength 670 nm

Volume of Sample 4 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 0 µL

Incubation time 1 600 s

Incubation Time 2 0

Stabilisation Time 5 s

OPTIONS

Linearity Limit 400 mg/dL

Blank Absorbance Limit 0 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 115 mg/dL

Lower Reference Range 75 mg/dL

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 500 µL

Temperature 37 ºC # User defined parameters

GLUCOSE GOD FS Order information

Cat. No. 1 2500 .. .. …

Notes

1. Please refer to the package insert for Glucose GOD FS for

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 12: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test HDL-Col

Units mg/dL

Analysis Mode Final Point

Associated constituents #

Reaction Type Increase

Sample replicates 1

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 0

Reading Bichromatic

Primary Wavelength 505 nm

Reference Wavelength 700 nm

Volume of Sample 4 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 100 µL

Incubation time 1 300 s

Incubation Time 2 300 s

Stabilisation Time 10 s

OPTIONS

Linearity Limit 180 mg/dL

Blank Absorbance Limit 0 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 35 mg/dL

Lower Reference Range # mg/dL

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

HDL-C IMMUNO FS Order information

Cat. No. 1 3521 .. .. …

Notes

1. Please refer to the package insert for HDL-C Immuno FS for

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 13: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test AST/GOT

Units U/L

Analysis Mode Kinetic

Associated constituents #

Reaction Type Decrease

Sample replicates 1

Value of the factor 1745

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Monochromatic

Primary Wavelength 340 nm

Reference Wavelength -

Volume of Sample 40 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 0 µL

Incubation time 1 50 s

Incubation Time 2 60 s

Stabilisation Time 30 s

OPTIONS

Linearity Limit 600 U/L

Blank Absorbance Limit 1 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 35 U/L

Lower Reference Range #

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

ASAT(GOT) FS (IFCC mod.) Order information

Cat. No. 1 2601 .. .. …

Notes

1. Please refer to the package insert for ASAT(GOT) FS (IFCC

Mod) for detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 14: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test ALT/GPT

Units U/L

Analysis Mode Kinetic

Associated constituents #

Reaction Type Decrease

Sample replicates 1

Value of the factor 1745

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Monochromatic

Primary Wavelength 340 nm

Reference Wavelength -

Volume of Sample 40 µL

Volume of Reagent 1 400 µL

Volume of Reagent 2 0 µL

Incubation time 1 50 s

Incubation Time 2 60 s

Stabilisation Time 30 s

OPTIONS

Linearity Limit 600 U/L

Blank Absorbance Limit 1 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 41 U/L

Lower Reference Range #

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 400 µL

Temperature 37 ºC # User defined parameters

ALAT(GPT) FS (IFCC mod.) Order information

Cat. No. 1 2701 .. .. …

Notes

1. Please refer to the package insert for ALAT(GPT) FS (IFCC

Mod) for detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 15: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test Triglycerides

Units mg/dL

Analysis Mode Final Point

Associated constituents #

Reaction Type Increase

Sample replicates 1

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 2

Reading Bichromatic

Primary Wavelength 546 nm

Reference Wavelength 670 nm

Volume of Sample 5 µL

Volume of Reagent 1 500 µL

Volume of Reagent 2 0 µL

Incubation time 1 600 s

Incubation Time 2 0

Stabilisation Time 10 s

OPTIONS

Linearity Limit 1000 mg/dL

Blank Absorbance Limit 0 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 200 mg/dL

Lower Reference Range # mg/dL

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 500 µL

Temperature 37 ºC # User defined parameters

TRIGLYCERIDES FS Order information

Cat. No. 1 5710 .. .. …

Notes

1. Please refer to the package insert for Triglycerides FS for

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

Page 16: ⠀䈀吀匀 ㌀㜀 尩 - Asterisco · BTS 370 Test Cholesterol Units mg/dL Analysis Mode Final Point Associated constituents # Reaction Type Increase Sample replicates 1 Calibrator

October 2008/1

BTS 370

Test Urea

Units mg/dL

Analysis Mode Fixed Time

Associated constituents #

Reaction Type Decrease

Sample replicates 1

Calibrator #

Rep Calibrator and Blank 2

Number of Calibrators #

Calibrator 1 *

Decimals 1

Reading Monochromatic

Primary Wavelength 340 nm

Reference Wavelength -

Volume of Sample 5 µL

Volume of Reagent 1 500 µL

Volume of Reagent 2 0 µL

Incubation time 1 50 s

Incubation Time 2 60

Stabilisation Time 30 s

OPTIONS

Linearity Limit 300 mg/dL

Blank Absorbance Limit 0 A

Kinetic Blank Limit 2 A/min

High Factor Limit #

Low Factor Limit #

Upper Reference Range 43

Lower Reference Range 17

Number of Controls #

Control Types #

Control Replicates #

Washing Volume 500 µL

Temperature 37 ºC # User defined parameters

UREA FS Order information

Cat. No. 1 3101 .. .. …

Notes

1. Please refer to the package insert for Urea FS for detailed

information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.